A prominent environmental group has claimed that water fluoridation in Ireland invalidates a new EU Medicines Directive.

“A key EU Directive, 2004/ 27/EC, Medicinal Products for Human Use, which came into force across the EU on October 30, will not be capable of being transposed into Irish law until the Government ends drinking water fluoridation. Under the Directive, the fluoride added to drinking water is a medicine and as such requires marketing authorisation, which it has never obtained either in Ireland or the EU,” said VOICE (Voice of Irish Concern for the Environment) campaigner Mr Robert Pocock.

He stated that VOICE has been alerting people for some time to “the failure of the Irish Medicines Board to implement previous and similar EU law on medicines by allowing 2.8 million people to be dosed with this unauthorised medicine via their drinking water”. According to Mr Pocock, the new Medicinal Products Directive again defines a medicinal product as “any substance… presented as having properties for treating or preventing disease in human beings”.

“Almost every time the Health Minister refers to the fluoride added to water she claims that it prevents the disease of dental caries. Yet her Department appears never to have checked why the Irish Medicines Board – responsible to her – has not, if it is a medicine, issued a product authorisation for the fluoride chemical used,” he said.

Mr Pocock pointed out that in 1983 the European Court of Justice had ruled that if a product is represented as having a beneficial effect on some medical condition then that product is a medicine under the terms of the Directive, “even if it is in fact ineffective”. The Irish Medicines Board has reinforced this interpretation in Guidelines on Medicinal Products (4) by quoting the ECJ ruling: “A product which is recommended or described as having preventive or curative properties is a medicinal product… even if it is generally considered as a foodstuff and even if it has no known therapeutic effect in the present state of scientific knowledge.”